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Идёт набор NCT07318129

Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis

Без фазы С лечением Relapsing Remitting Multiple Sclerosis (RRMS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Placebo, Indole-3-propionic acid (IPA).
Кому может быть актуально
Состояния в реестре: Relapsing Remitting Multiple Sclerosis (RRMS). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis (iPROACT-MS)

Обзор

This study, iPROACT-MS, is part of the iPROACT group of clinical trials aiming to investigate the effects of oral supplementation with indole-3-propionic acid (IPA) in humans. IPA is naturally produced as a gut bacterial metabolite with the amino acid tryptophan as substrate. The primary aim of iPROACT-MS is to investigate whether patients with relapsing-remitting multiple sclerosis (RRMS) can benefit from supplementation with IPA. The hypothesis is that supplementation with IPA will protect against MS-related disease activity, neurodegeneration and metabolic abnormalities. Secondary, iPROACT-MS aims at elucidating the complex relationships between lifestyle, gut microbial factors, inflammation, oxidative stress, metabolic health, MS disease severity and MS disease activity.

Вмешательства

  • Пищевая добавка Placebo
    Two capsules are taken every morning and two capsules are taken every evening for 27 consecutive months. Placebo capsules are taken orally.
  • Пищевая добавка Indole-3-propionic acid (IPA)
    Two capsules are taken every morning and two capsules are taken every evening for 27 consecutive months. Active capsules are taken orally and contain 250 mg of IPA each resulting in a total daily dose of 1000 mg of IPA.

Первичные конечные точки

  • No evidence of disease activity (NEDA) [Срок оценки: The time between month 3 and month 27 after initiation of supplementation.]
Вторичные конечные точки (12)
  • Annualized relapse rate evaluated at month 27 [Срок оценки: The time between month 3 and month 27 after initiation of supplementation.]
  • Total (cumulative) number of new or enlarged T2-weighted/FLAIR brain lesions per scheduled yearly MRI evaluated at month 27 [Срок оценки: The time between month 3 and month 27 after initiation of supplementation.]
  • Serum neurofilament light chain (sNfL) [Срок оценки: Evaluated longitudinally at months 0, 3, 15 and 27.]
  • Percentage of patients with disability improvement confirmed at 3 months [Срок оценки: The time between month 3 and month 27 after initiation of supplementation.]
  • The time to onset of disability worsening confirmed at 3 months [Срок оценки: The time between month 3 and month 27 after initiation of supplementation.]
  • Cumulative change in EDSS score [Срок оценки: The time between month 3 and month 24 after initiation of supplementation.]
  • Multiple Sclerosis Functional Composite (MSFC) [Срок оценки: The time between month 0 and month 24 after initiation of supplementation.]
  • Symbol Digit Modalities Test (SDMT) [Срок оценки: The time between month 0 and month 24 after initiation of supplementation.]
  • California Verbal Learning Test-II (CVLT-II) [Срок оценки: The time between month 0 and month 24 after initiation of supplementation.]
  • Brief Visuospatial Memory Test - Revised (BVMR-R) [Срок оценки: The time between month 0 and month 24 after initiation of supplementation.]
  • Intra-eye change in peripapillary retinal nerve fiber layer (RNFL) thickness [Срок оценки: The time between month 0 and month 24 after initiation of supplementation.]
  • Intra-eye change in ganglion cell and inner plexiform layer (GCIPL) thickness [Срок оценки: The time between month 0 and month 24 after initiation of supplementation.]

Критерии участия

Критерии включения

  • Women and men ≥18 and ≤65 years of age
  • Diagnosed with RRMS according to the 2017 McDonald criteria (or newer updates)
  • Routinely treated and monitored for MS
  • Speak and read Danish
  • Deemed physically and mentally able to participate in this study

Критерии исключения

  • Active malignancy
  • Diagnosis of Crohn's disease and ulcerative colitis
  • Other comorbidities deemed to be relevant
  • Haematopoietic stem cell transplantation
  • Current or past treatment with non-MS related treatments deemed to be relevant
  • Pregnancy or lactation
  • People with MR contraindications:
  • Severe claustrophobia
  • Incompatible implants/ foreign objects, including implanted pacemakers, heart valve prostheses, prostheses in the middle ear, implanted devices (e.g., insulin pump), metal debris, e.g., metal splinters in the eyes, miscellaneous shunts and catheters, metal clips from operations

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Дания · 1 центр
  • Glostrup Hospital — Glostrup Municipality

Идентификаторы

NCT: NCT07318129 · H-25042489

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗